- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001790
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children With Fever and Neutropenia
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Children ages 2-17 with neutropenia (absolute count less than or equal 5000/mm(3)) and one or more of the following conditions: leukemia or lymphoma, excluding those patient's on maintenance therapy; bone marrow or peripheral stem cell transplantation; aplastic anemia; myelodysplastic syndrome; chemotherapy anticipated to incur greater than 10 days of neutropenia.
Patients with new onset of fever during neutropenia who will be initiated onto broad spectrum empirical antibacterial therapy.
Patients must have sufficient venous access to permit administration of study drug, collection of pharmacokinetic samples and monitoring of safety variables.
Concomitant therapies: Patients may have received or continue to receive antineoplastic therapies and medications for supportive care.
Females of childbearing potential must have a negative pregnancy test and must agree to use barrier methods of contraception throughout the study.
Informed consent of the patient, parent, or legally authorized representative obtained prior to entry.
Verbal assent will be obtained from minors capable of understanding.
No patients with active proven deeply invasive fungal infection.
No patients with moderate or severe liver disease, as defined by: AST or ALT greater than 2.5 times the upper limit of normal or total bilirubin greater than 2.5 times the upper limit of normal.
No patients who have received intravenous amphotericin B or formulations of amphotericin B within 72 hours of entering the study or who require treatment with systemic antifungal agents other than FK463. Patients may continue to receive fluconazole prophylactically (no more than 400mg/day or 12mg/kg/day) while on study. All other systemic antifungals agents must be discontinued prior to the first dose of FK463.
No patients who are on other phase I trials of investigational agents.
No patients previously enrolled into this study.
No other concomitant condition which, in the opinion of the investigator, would preclude a patient's participation in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Walsh TJ, Gonzalez C, Lyman CA, Chanock SJ, Pizzo PA. Invasive fungal infections in children: recent advances in diagnosis and treatment. Adv Pediatr Infect Dis. 1996;11:187-290. No abstract available.
- Berenguer J, Buck M, Witebsky F, Stock F, Pizzo PA, Walsh TJ. Lysis-centrifugation blood cultures in the detection of tissue-proven invasive candidiasis. Disseminated versus single-organ infection. Diagn Microbiol Infect Dis. 1993 Aug-Sep;17(2):103-9. doi: 10.1016/0732-8893(93)90020-8.
- Pizzo PA, Robichaud KJ, Gill FA, Witebsky FG. Empiric antibiotic and antifungal therapy for cancer patients with prolonged fever and granulocytopenia. Am J Med. 1982 Jan;72(1):101-11. doi: 10.1016/0002-9343(82)90594-0. No abstract available.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 990007
- 99-C-0007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mycoses
-
Steven B. KleiboekerNational Institute of Allergy and Infectious Diseases (NIAID)WithdrawnAdenovirus | Other MycosesUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
Fungal Infection Study ForumMerck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Xiamen Amoytop Biotech Co., Ltd.Shanghai Jiao Tong University Affiliated First People's HospitalCompleted
-
Institut National de la Santé Et de la Recherche...UnknownCandidiasisBelgium, France, Italy, Netherlands, Spain
-
PfizerVicuron PharmaceuticalsCompleted
-
Daniel BenjaminEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedFluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams BirthweightCandidiasisUnited States
-
Merck Sharp & Dohme LLCCompleted
Clinical Trials on FK463
-
Astellas Pharma IncCompletedCandidemia | Invasive Candidiasis | Esophageal Candidiasis | Oropharyngeal CandidiasisUnited States, South Africa
-
Astellas Pharma IncCompleted
-
Astellas Pharma S.A.S.CompletedUse of Micafungin (Mycamine®) as Antifungal Prophylaxis in Haematology and Onco-haematology (OLYMPE)Antifungal Prophylaxis | HaemopathyFrance
-
Astellas Pharma IncCompleted
-
Astellas Pharma IncCompletedCandidemia | Invasive Candidiasis | Esophageal Candidiasis | Oropharyngeal CandidiasisUnited States
-
Astellas Pharma IncCompletedCandidiasisUnited Kingdom, Austria, France, Germany, Italy, Poland, Spain, Sweden
-
Asan Medical CenterAstellas Pharma Korea, Inc.UnknownNeutropenia | Hematopoietic Stem Cell Transplantation | Invasive Fungal DiseaseKorea, Republic of
-
Astellas Pharma IncCompletedAspergillosisUnited Kingdom, Austria, France, Germany, Italy, Poland, Spain, Sweden
-
Astellas Pharma IncTerminatedComparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICUInvasive Fungal InfectionsUnited States, Canada
-
Astellas Pharma Singapore Pte. Ltd.CompletedInvasive Fungal InfectionsHong Kong, Korea, Republic of, Singapore, Taiwan, Thailand